ASCO is a strong proponent of preserving and enhancing our federally funded clinical trials system. The IOM Committee developed evidence-based support for the value of our system and the essential role it plays in the prevention and cure of cancer.

The ASCO report has been updated to reflect additional changes that have taken place as a result of:

The NCI Board of Scientific Advisors approval of NCI's overview of its proposed changes (Request for Applications (RFA) concept) at its November 2011 meeting and

The Department of Health and Human Services' Office for Human Research Protections (OHRP) Advanced Notice of Proposed Rulemaking in July 2011 that indicated the Department's interest in implementing some of the changes discussed in the IOM report recommendations.

At its November 7 meeting, the NCI Board of Scientific Advisors approved the NCI’s plan for reorganization of the Cooperative Group program. NCI is working on the new request for applications (RFA) that will undergo internal NCI and NIH review. Projected date for RFA issuance is July 2012.

July 22, 2011: Summary of IOM-ASCO Workshop

The Institute of Medicine (IOM) issued a summary of the March 21, 2011, workshop jointly sponsored by the IOM’s National Cancer Policy Forum and ASCO that brought together clinical trials stakeholders, ASCO members, and federal agency representatives. The report summarizes the discussion of how to increase the efficiency and productivity of the clinical trials system, including efforts to consolidate the existing Cooperative Groups, public-private collaboration, funding, and ensuring broad involvement of patients and healthcare providers.

ASCO’s recommendations were highlighted in a presentation by Jeff Abrams, MD, associate director of the NCI Cancer Therapy Evaluation Program, to the NCI Clinical Trials and Translational Research Advisory Committee (CTAC) on July 13, 2011. Dr. Abrams and CTAC members discussed an in-depth many of the points raised in ASCO’s letter and other issues that would help ensure that the reorganized system is best equipped to promote scientific innovation and efficiently administer clinical trials.

An ASCO report released July 6, 2011 analyzes progress in restructuring of the Cooperative Group Program and implementation of the IOM recommendations. ASCO issued this status report to document actions taken to date and outline areas where progress is still needed. ASCO will periodically issue updates to this report and continue to advocate and support implementation of all the report recommendations. In addition, ASCO is working with the IOM to plan a follow-up workshop.

June 28, 2011: NCI Response to ASCO Comment Letter

On June 28, 2011, National Cancer Institute Director Harold Varmus, MD, and James Doroshow, MD, NCI deputy director for clinical and translational sciences, sent a three-page letter to ASCO immediate past president George W. Sledge Jr., MD, replying in detail to ASCO’s recommendations regarding short- and long-term metrics for a successful reorganization.

June 7, 2011: ASCO Comments to NCI on its Reorganization Plans

In a letter to Dr. Harold Varmus, director of the NCI, ASCO expressed overall support of NCI’s efforts to strengthen and transform the Cooperative Group Program. NCI has proposed significant changes to the Cooperative Group Program. ASCO believes it is essential that NCI define in advance specific metrics for determining the success of the reorganization. The letter outlined five broad goals that could be used as the basis for development of these outcomes measures.

March 21, 2011: IOM-ASCO Implementation Workshop

In March 2011, IOM and ASCO jointly sponsored a workshop that assembled all the stakeholders in the Cooperative Group Program to discuss the report’s recommendations and identify activities planned in response to the IOM report on the cooperative groups. ASCO is working with the IOM to plan a follow-up workshop.

April 5, 2011: ASCO Press Release on IOM Report

ASCO issued a press release in response to the IOM report and expressed support for full adoption of its recommendations.